Cleared Traditional

K791649 - TETRAHYDROCANNALBINOL DIRECT BLOOD KIT

K791649 is the FDA 510(k) clearance for TETRAHYDROCANNALBINOL DIRECT BLOOD KIT by Immunalysis Corporation. It is a Class 2 Toxicology device (product code LAT) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K791649 · Immunalysis Corporation · Toxicology device
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Oct 1979
Decision
48d
Days
Class 2
Risk

K791649 is an FDA 510(k) clearance for the TETRAHYDROCANNALBINOL DIRECT BLOOD KIT. Classified as Radioimmunoassay, Cannabinoid(s) (product code LAT), Class II - Special Controls.

Submitted by Immunalysis Corporation (Mchenry, US). The FDA issued a Cleared decision on October 11, 1979 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immunalysis Corporation devices

Submission Details

510(k) Number K791649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1979
Decision Date October 11, 1979
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAT Radioimmunoassay, Cannabinoid(s)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.